Vaccine Therapy in Treating Patients With Malignant Melanoma

Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128583

Enrollment

Unknown

Registered

2005-08-10

Start date

2005-07-31

Completion date

Unknown

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage III melanoma

Brief summary

RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

Detailed description

OBJECTIVES: * Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™). OUTLINE: This is an open-label, multicenter study. Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™). After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Interventions

BIOLOGICALpolyvalent melanoma vaccine

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Design outcomes

Primary

Measure	Time frame
Response	—

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026